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Where Can You Report your Adverse Drug Reactions or Adverse Events Following Immunization

 
Where Can You Report your Adverse Drug Reactions or Adverse Events Following Immunization
 

This section provides a comprehensive overview of the procedures and tools available to Healthcare Professionals, Market Authorization Holders and the General Public to report adverse events associated with medicinal products and vaccines in Lebanon.
 
How to report

You can send the case reports using the following tools:
 
  1. For Healthcare Professionals and the Public
The Lebanese National Pharmacovigilance Program has adapted two user-friendly tools: one for Adverse Drug Reactions (Vigimobile e-Reporting e-Form) and another for reporting Adverse Events Following Immunization (Vigimobile e-Form). Both tools may be accessed by healthcare professionals and the general public.
 
  1. The VigiMobile e-Form and e-Reporting e-Form:
The VigiMobile e-Form and e-Reporting e-Form are the latest tools launched in January 2025 by the Lebanese National Pharmacovigilance Program. These digital platforms were introduced to enhance the reporting process, with the e-Reporting e-Form designed for Adverse Drug Reactions (ADRs) and the VigiMobile e-Form specifically for Adverse Events Following Immunization (AEFIs).

How to Download on Android Phones
 
  1. Scan the QR Code by pressing the link
  2. Click the three dots in the top-right corner
  3. Choose Install app
  4. VigiMobile e-Form/e-Reporting e-Form now appears as an app
 
How to Download on Apple IOS Phones
 
  1. Scan the QR Code by pressing the link
  2. Click on the share button
  3. Add VigiMobile to the home screen
  4. VigiMobile e-Form/e-Reporting e-Form now appears as an app

How to Download on Windows
  1. Press on the link
  2. Install from the Browser menu
  3. VigiMobile e-Form/e-Reporting e-Form is now installed 
 
Scan QR Codes to Report:
  1. ADRs Following Medication Use
  1. AEFIs Following Vaccine Use
Or use the following link: LNPVP: e-Reporting eForm Or use the following link: LNPVP: VigiMobile eForm
 
  1. Direct Contact with the Lebanese National Pharmacovigilance Program:
You may contact the Lebanese National Pharmacovigilance Program through:
  • Email Address:
  • Phone number of the Quality Assurance of Pharmaceutical Products Program: 01-830254   
 
  1.  For Market Authorization Holders:
Based on the Ministerial Resolution MR #181 issued in 2021, MAHs should adhere to the internationally agreed ICH guidelines and standards and send the reports in XML format as specified in ICH E2B (R2 or R3) guidelines

(https://www.moph.gov.lb/userfiles/files/Quality%26Safety/PharmacovigilanceSystemInLebanon/Karar%20181-2021.pdf).

All XML files should be sent to the following emails: pv@moph.gov.lb, and pv.moph@gmail.com.
 
As for what to report or report type, you can refer to Module VI:
https://moph.gov.lb/en/Pages/4/44742/pharmacovigilance-system-lebanon#/en/view/70479/lebanese-guideline-on-good-pharmacovigilance-practices-lgvp-
 
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ATC Name B/G Ingredients Dosage ↓ Form Price
R05CA12 HEDERAL G Dried Ivy leaf extract (Hedera Helix) - 99mg/5ml 99mg/5ml Drops solution 384,339 L.L
R02AA20 HEXASPRAY COLLUTOIRE PRESSURISE B Biclotymol - 750mg 750mg Spray 353,431 L.L
J07BC02 HAVRIX JUNIOR 720 B Hepatitis A, inactivated, whole virus - 720 ELISA units/0.5ml 720 ELISA units/0.5ml Injectable suspension 1,491,665 L.L
B01AB12 HIBOR G Bemiparin Sodium - 7,500IU 7,500IU Injectable solution 2,198,526 L.L
B02BX06 HEMLIBRA BioTech Emicizumab - 60mg/0.4ml 60mg/0.4ml Injectable solution 441,042,377 L.L
N05CD08 HIKMA MIDAZOLAM G Midazolam (HCl) - 5mg/ml 5mg/ml Injectable solution 679,984 L.L
G04BE08 HEROX G Tadalafil - 5mg 5mg Tablet, film coated 1,416,410 L.L
N05AD01 HALDOL B Haloperidol - 5mg 5mg Tablet 231,141 L.L
N05AD01 HALOPERIDOL G Haloperidol - 5mg 5mg Tablet 276,448 L.L
C08CA01 HYPODIPINE 5 G Amlodipine (besylate) - 5mg 5mg Capsule 362,837 L.L
N05AD01 HALDOL DECANOAS B Haloperidol (Decanoate) - 50mg/ml 50mg/ml Injectable solution 444,812 L.L
C03BA04 HYGROTON B Chlortalidone - 50mg 50mg Tablet 422,351 L.L
C03DA04 HEPERONA 50 G Eplerenone - 50mg 50mg Tablet, coated 2,150,148 L.L
A11CC05 HI DEE G Vitamin D3 - 5000IU 5000IU Capsule, soft gelatin 740,457 L.L
A11CC05 HI DEE G Vitamin D3 - 50000IU 50000IU Capsule, soft gelatin 518,723 L.L
B01AB12 HIBOR G Bemiparin Sodium - 5,000IU 5,000IU Injectable solution 1,466,132 L.L
D11AX01 HAIRGAINE 5 G Minoxidil - 5% 5% Solution 1,963,354 L.L
D11AX01 HAIRGROW G Minoxidil - 5% 5% Solution 1,061,636 L.L
L01CE01 HYCAMTIN IV B Topotecan HCl - 4mg 4mg Injectable lyophilised powder for solution 52,580,031 L.L
L01CE01 HYCAMTIN IV B Topotecan HCl - 4mg 4mg Injectable lyophilised powder for solution 52,580,031 L.L
L01FD01 HERZUMA BioTech Trastuzumab - 440mg 440mg Injectable powder for concentrate for solution 89,046,707 L.L
L04AB04 HUMIRA BioTech Adalimumab - 40mg/0.4ml 40mg/0.4ml Injectable solution L.L
L04AB04 HUMIRA BioTech Adalimumab - 40mg/0.4ml 40mg/0.4ml Injectable solution 33,860,031 L.L
B01AB05 HEPAXANE 4000IU BioTech Enoxaparin sodium - 40mg/0.4ml 40mg/0.4ml Injectable solution 4,063,780 L.L
L04AB04 HYRIMOZ BioTech Adalimumab - 40mg 40mg Injectable solution 27,521,893 L.L
L04AB04 HYRIMOZ BioTech Adalimumab - 40mg 40mg Injectable solution 27,521,893 L.L
B03XA01 HEMAX BioTech Erythropoietin recombinant human (Epoetin alfa) - 40,000IU 40,000IU Injectable freeze dried powder + diluent 6,316,060 L.L
B03XA01 HEMAX BioTech Erythropoietin recombinant human (Epoetin alfa) - 4,000IU 4,000IU Injectable freeze dried substance+diluent 940,690 L.L
B03XA01 HEMAX BioTech Erythropoietin recombinant human (Epoetin alfa) - 4,000IU 4,000IU Injectable freeze dried substance+diluent 33,852,747 L.L
R05CA12 HEDERAL G Dried Ivy leaf extract - 37mg/5ml 37mg/5ml Syrup 309,084 L.L
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